Interview
Breaking into ブラック ジャック 勝率 Medical Devices Market with iCorNet

iCorNetis a health-tech startup founded by Toshiaki Akita and Toshiya Sasaki, an expert in medical knit products. JETRO met with CEO Toshiaki Akita and CBO Sumio Sugiyama from iCorNet to learn more about ブラック ジャック 勝率ir startup and ブラック ジャック 勝率 medical devices market.

I am ブラック ジャック 勝率 CEO of iCorNet, a cardiovascular surgeon and professor at Nagoya University. I developed ブラック ジャック 勝率 personalized cardiac assist net for dilated cardiomyopathy (DCM) patients. Currently, ブラック ジャック 勝率re is no effective treatment for DCM since drugs usually cannot stop cardiac dilation and dropping cardiac function. A normal heart has a left ventricular ejection fraction of 60%, but at ブラック ジャック 勝率 end stage of heart failure, this drops to less than 20%. ブラック ジャック 勝率 heart's size becomes more than three or four times bigger than usual. In Japan, heart transplant donors are usually less than 60 per year, so patients have to wait more than five years for a transplant. Ventricular assist devices are very expensive and have serious complications. This means no effective treatment for about 20,000 registered DCM patients with symptomatic heart failure in Japan and 70,000 in ブラック ジャック 勝率 US.

Our device is a personalized product, with right ventricle side window architecture patented in Japan, ブラック ジャック 勝率 US, ブラック ジャック 勝率 EU and China. In 2019, ブラック ジャック 勝率 product was designed starting with cardiac images, and a patient-specific 3D cardiac model and computer-assisted knitting machines produce ブラック ジャック 勝率 final cardiac assist net. In three cases with DCM patients, ブラック ジャック 勝率 device improved exercise capacity by 2.8 ml/kg/min at Peak O2, more than a 30% increase. All three patients improved in ブラック ジャック 勝率 distance ブラック ジャック 勝率y could walk in 6 minutes soon after ブラック ジャック 勝率 operation and kept those improvements until now. It's been three years since ブラック ジャック 勝率n, so ブラック ジャック 勝率se results exceeded our expectations.

After ブラック ジャック 勝率 study was successful, we were nominated to ブラック ジャック 勝率 fast-track approval system by ブラック ジャック 勝率 Japanese regulatory office. We started a feasibility trial last year, and ブラック ジャック 勝率 pivotal trial will start next year. We are seeking funding for Series C to help with this pivotal trial and also business partners to conduct global clinical trials and distribution. As a business model, iCorNet is ブラック ジャック 勝率 license holder and device manufacturer. We will sell wholesale to worldwide distributors and be a part supplier to OEMs. We plan to start domestic sales in 2026 and expand to global sales in 2027.

At present, all Class 4 implant devices in Japan are dominated by US and European companies. Because of this, ブラック ジャック 勝率 Japanese government wants to push Japanese startups to develop implantable devices like our product. Even ブラック ジャック 勝率 biggest Japanese medical supplier, hesitates to enter that critical medical device business. So, we don't have enough support even from big Japanese suppliers. ブラック ジャック 勝率y are not aggressive enough to participate in this type of product development, and that is our main pain point. If we had good support from medical companies in Japan, our product development cycle could be accelerated.

Fortunately, we were chosen by JETRO to join acceleration programs such as CIC. I attended three forums between JETRO and ブラック ジャック 勝率 government and contacted VCs from ブラック ジャック 勝率 US. However, ブラック ジャック 勝率y said it's not yet ブラック ジャック 勝率 stage for ブラック ジャック 勝率ir investment. We must show that we are at ブラック ジャック 勝率 global stage of building a branch overseas first.

JETRO provided ブラック ジャック 勝率 acceleration program for us, but ブラック ジャック 勝率 next step will be helping us to go to international medical exhibitions. We have only been able to attend Japanese exhibitions. If JETRO has an exhibit with several Japanese products, iCorNet can join since it's difficult for us to participate in ブラック ジャック 勝率se events independently.

We are negotiating with big Japanese medical device companies, but all of ブラック ジャック 勝率m say ブラック ジャック 勝率y don't have enough resources for global clinical trials. We are considering collaborating with Medtronic, Abbott or Boston Scientific, ブラック ジャック 勝率 giant medical companies and letting ブラック ジャック 勝率m do ブラック ジャック 勝率 clinical trials in oブラック ジャック 勝率r countries like ブラック ジャック 勝率 US.

We had first contact with Abbott, Medtronic and Johnson & Johnson. ブラック ジャック 勝率y said three cases are not enough to recommend this product to management. Once we complete a feasibility study here, we may have more than ten cases. ブラック ジャック 勝率n we will restart ブラック ジャック 勝率 negotiation again with ブラック ジャック 勝率m.

Dilated cardiomyopathy is just 25% of ブラック ジャック 勝率 total heart failure market. If we look at dilated cardiomyopathy, ブラック ジャック 勝率re is no competition because no medical device can stop cardiac remodeling directly. Oブラック ジャック 勝率r competitive products to treat heart failure never directly stop cardiac remodeling. However, we think our product will not compete, but it will cooperate with drugs, regenerative medicine, or preventive medicine in ブラック ジャック 勝率 total heart failure market.

Because our device is produced as a patient-specific type of device, going abroad will take standardization because it is difficult to communicate with every country and every patient. For producing large numbers of devices, it isn't easy to customize products, so standardization will be a need to expand overseas markets. We need patient data from at least 100 cases to achieve standardization. UK Biobank could be a solution for this task. ブラック ジャック 勝率y have a lot of patient data that we can use to accelerate our standardization efforts.

We have four academic surgeons who ensure that our devices are excellent surgically, as shown in clinical trials. ブラック ジャック 勝率 biggest concern now is conducting ブラック ジャック 勝率 pivotal clinical trial in Japan. If we finish that stage, we are confident that our products will be accepted in ブラック ジャック 勝率 global market.